SAN FRANCISCO, CA — The biotech company Qvin™ recently announced the FDA clearance of its Q-Pad™ and A1c Test. The clearance makes it possible for the millions of women in America who live with diabetes to receive monitoring of hemoglobin A1c (HbA1c), using laboratory tests performed on the Q-Pad. More broadly, this marks an opportunity for testing important biomarkers for the more than 80 million people who menstruate in the US.
The traditional methods of blood testing require invasive procedures administered by medical professionals, which can be time-consuming and expensive. Not everyone has the access and financial means to get laboratory results for blood work. However, billions of people globally have their period every single month, and yet, menstrual samples have never previously been explored as a diagnostic source for health information.
Qvin™ proved the clinical relevancy of menstrual blood for several important biomarkers. Now, for the first time, menstrual blood can be used to provide insights for people with the Q-Pad and A1c Test, from the convenience of their own home. The U.S. FDA clearance of the Q-Pad and A1c Test, for at-home collection of samples and over-the-counter (OTC) distribution, speaks to the safety and simplicity of the Q-Pad™ technology.
How does the Q-Pad™ work?
"With the first-ever FDA-cleared menstrual blood health test, Qvin™ is paving the way to important new opportunities for women's health and this is just the beginning," said Sara Naseri, MD, co-founder and CEO at Qvin™. "We are simplifying routine testing, and freeing up resources that can be used on providing care, and ultimately our goal is to make health care much more accessible."
Each Q-Pad™ includes a removable strip: Once the Q-Pad™ has sufficiently collected a menstrual sample, the removed collection strip is sent to a CLIA-certified laboratory for clinical testing. Users receive their results via the free and convenient Qvin™ app.
The Qvin™ A1c Q-Pad™ Test Kit measures the average blood sugar over three months, by testing the HbA1c biomarker for people with diabetes. It's one of the most commonly used tests to monitor diabetes and pre-diabetes. Blood sugar levels can have health impacts, even in people without diabetes. "Utilizing menstrual samples, the Q-Pad™ can address critical women's health issues that have historically been neglected," stated Søren Therkelsen, BA, co-founder of Qvin™. "Because of our vertically integrated infrastructure, we will over time be able to deliver healthcare solutions at a significantly lower cost than traditional methods. We are proud to have developed a product that has the potential to vastly improve access to global health care."
The road ahead
Qvin™, in collaboration with researchers at academic institutions such as Stanford University School of Medicine, has published peer-reviewed research validating other biomarkers that can also be monitored. Q-Pad™ allows individuals to submit specimens directly to the lab and receive reports on key health conditions that often go undiagnosed or misdiagnosed including pre/diabetes, anemia, fertility, perimenopause, endometriosis, and thyroid health.
"The research and development that Qvin™ has undertaken are both highly novel and innovative in helping women better address their health concerns," said Paul Blumenthal, MD, MPH, professor emeritus of obstetrics and gynecology at Stanford University. "For instance, women seeking to understand their fertility status can soon monitor various reproductive hormones via menstrual blood using the Q-Pad™. In addition, published research indicates that the Q-Pad™ could be a convenient, user-friendly, and efficient way of screening for the human papillomavirus (HPV) as part of global cervical cancer prevention efforts."
- This press release is supported by Qvin™